Clinical trial · Interventional
Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML
Study of A Venetoclax-based, Anthracycline-free Regimen in Patients With Newly Diagnosed CBFβ::MYH11-positive Acute Myeloid Leukemia
NCT06429098CI-TRIAL-00094560active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azacitidine | Drug | Azacitidine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| decitabine | Drug | Decitabine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax, Azacitidine/Decitabine/, Cytarabine
- description
- INDUCTION: Patients receive 2 cycles of VEN/HMA as induction therapy. Venetoclax orally (PO) once daily (QD) on days 1-28, azacitidine subcutaneously (SC) on days 1-7 or decitabine intravenously (IV) over 30-60 minutes on days 1-5. CONSOLIDATION: Fit patients will receive four cycles of consolidation therapy with high-dose cytarabine (2g/m2 every 12 hours, on days 1-3) combined with venetoclax (on days 1-7). Unfit patients will continue to receive VEN/HMA until disease progression.
- interventionNames
- Drug: Venetoclax
- Drug: azacitidine
- Drug: decitabine
- Drug: Cytarabine
Primary outcomes (1)
- measure
- composite complete remission rate
- timeFrame
- after 2 cycles of induction therapy with VEN/HMA (each cycle is 28 days).
- description
- CR/CRi rate will be determined.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults ≥ 18 years. 2. Newly diagnosed CBFβ::MYH11(+) AML. 3. Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale. 4. Subject must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures. Ferrara's criteria are used to determine whether a patient is unfit, and a patient is deemed unfit if at least one of the following criteria is met: 1. Age\>75 years. 2. There are serious underlying heart, lung, kidney, liver complications. 3. There are active infections that do not respond to anti-infective therapy. 4. There is cognitive impairment. 5. Other comorbidities that the doctor determines are not suitable for intensive chemotherapy. Exclusion Criteria: 1. Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agents either conventional or experimental or targeted drug therapy for AML (except oral hydroxyurea and/or leukocytometry to reduce white blood cell count). 2. Pregnant or lactating women. 3. To the knowledge of the subject and investigator, subject may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or be unable to comply with the required study procedures. 4. Other conditions deemed unsuitable for participation in this study by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.